A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
NCT ID: NCT01668862
Last Updated: 2012-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2012-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study arm A
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
Autologous Human Platelet Lysate
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
Control Arm B
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Corticosteroid
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Interventions
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Autologous Human Platelet Lysate
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
Corticosteroid
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Eligibility Criteria
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Inclusion Criteria
* Subjects both male and female, aged 18-60 years (both inclusive)
* Subjects who are willing to give informed consent and adhere to the study protocol
Exclusion Criteria
* Subjects with autoimmune diseases
* Subjects with immuno-compromised system
* Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
* Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
* Subjects who have received treatment with corticosteroid injections within the last 6 months
18 Years
60 Years
ALL
No
Sponsors
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Kasiak Research Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Anant Joshi, Dr.
Role: PRINCIPAL_INVESTIGATOR
ASMI
Nicolas Antao, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hillway Clinic
Gauresh Palekar, Dr.
Role: PRINCIPAL_INVESTIGATOR
Surya Orthopedic Clinic
Locations
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Kasiak Research Pvt Ltd
Thāne, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Kaushal Shah, Phd
Role: primary
Other Identifiers
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KRPL/HPL-TE/11-12/003
Identifier Type: -
Identifier Source: org_study_id